Lacosamide Accord

Package leaflet: Information for the patient

Lacosamide Accord 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

lacosamide
Read this entire leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Lacosamide Accord is and what it is used for
2. What you need to know before taking Lacosamide Accord
3. How to take Lacosamide Accord
4. Possible side effects
5. How to store Lacosamide Accord
6. Contents of the pack and other information

1. What is Lacosamide Accord and what is it used for

What is Lacosamide Accord
Lacosamide Accord contains the active substance lacosamide. It belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.

• This medicine has been prescribed to you to reduce the number of seizures (epileptic fits) you experience.

What Lacosamide Accord is used for

• Lacosamide Accord is used: alone or in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age for the treatment of a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation.
• In this type of epilepsy, seizures initially involve only one side of your brain. However, they may then spread to wider areas on both sides of your brain;
• in combination with other antiepileptic medicines in adults, adolescents and children from 4 years of age for the treatment of primary generalised tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Lacosamide Accord

Do not take Lacosamide Accord

• if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor.
• if you are allergic to peanuts or soya.
• if you have a specific type of heart rhythm problem called second- or third-degree AV block.

Do not take Lacosamide Accord if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Lacosamide Accord if:

• you have had thoughts of harming or killing yourself. A small number of people treated with antiepileptic medicines such as lacosamide have had suicidal thoughts. If you experience such thoughts at any time, inform your doctor immediately.
• you have a heart condition affecting your heartbeat and often experience a particularly slow, fast, or irregular heartbeat (e.g. AV block, atrial fibrillation, or atrial flutter).
• you have a serious heart condition, such as heart failure or have had a heart attack.
• you frequently feel dizzy or have falls. Lacosamide Accord may cause dizziness, which could increase the risk of accidental injury or falls. Therefore, you should be cautious until you are accustomed to the effects of this medicine.

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Accord.

If you are currently taking Lacosamide Accord, contact your doctor if you experience seizures of a different type or if your existing seizures worsen.

If you are taking Lacosamide Accord and develop symptoms of an abnormal heartbeat (such as slow, rapid, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).

Children

Lacosamide Accord is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures, and is not recommended for children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether the medicine is effective or safe in children within these age groups.

Other medicines and Lacosamide Accord

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, because Lacosamide Accord may also affect your heart:

• medicines used to treat heart diseases;
• medicines that can prolong the "P-R interval" on a heart scan (ECG or electrocardiogram), such as antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of irregular heartbeat or heart failure.

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Accord.

• Also inform your doctor or pharmacist if you are taking any of the following medicines—because they may increase or decrease the effect of Lacosamide Accord in your body: antifungal medicines called fluconazole, itraconazole, or ketoconazole;
• an HIV medicine called ritonavir;
• medicines used to treat bacterial infections, called clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression, called St. John’s wort.

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Accord.

Lacosamide Accord and alcohol

As a precautionary safety measure, do not take Lacosamide Accord with alcohol.

Pregnancy and breastfeeding

Women of childbearing potential should discuss the use of contraceptive measures with their doctor.

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

It is recommended not to take Lacosamide Accord during pregnancy, as the effects of lacosamide on the fetus are not fully known. It is also recommended not to breastfeed while taking Lacosamide Accord, as lacosamide passes into breast milk. Consult your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not you should take Lacosamide Accord.

Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures (episodes). Worsening of your condition may also be harmful to your baby.

Driving and using machines

Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Lacosamide Accord may cause dizziness or blurred vision.

3. How to take Lacosamide Accord

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
How to take Lacosamide Accord

• Take Lacosamide Accord twice daily – approximately 12 hours apart.
• Try to take it at about the same time each day.
• Swallow the Lacosamide Accord tablet with a glass of water.
• You may take Lacosamide Accord with or without food.

You will usually start on a lower daily dose, which your doctor will gradually increase over several weeks. Once the appropriate dose for you has been reached, this is called the "maintenance dose", so you will take the same amount every day. Lacosamide Accord is used as a long-term treatment. You must continue taking Lacosamide Accord until your doctor tells you to stop.
Dosage
Below are the usual recommended doses of Lacosamide Accord for different age groups and weight categories. Your doctor may prescribe a different dose if you have kidney or liver problems.
Adolescents and children weighing 50 kg or more, and adults
When taking Lacosamide Accord as monotherapy:
The usual starting dose of Lacosamide Accord is 50 mg twice daily.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 200 mg twice daily.
When taking Lacosamide Accord with other antiepileptic medicines:
The usual starting dose of Lacosamide Accord is 50 mg twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, until reaching a maintenance dose ranging from 100 mg to 200 mg twice daily.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide Accord using a single 200 mg loading dose. Twelve hours later, you would then start your maintenance dose.
Children and adolescents weighing less than 50 kg

• For the treatment of partial-onset seizures: note that Lacosamide Accord is not recommended in children below 2 years of age.
• For the treatment of primary generalized tonic-clonic seizures: note that Lacosamide Accord is not recommended in children below 4 years of age.

The dose depends on their body weight. Treatment usually starts with the oral syrup, and patients may switch to tablets only if they are able to swallow them and can receive the correct dose with the available tablet strengths. Your doctor will prescribe the most suitable formulation for them.
If you take more Lacosamide Accord than you should
Contact your doctor immediately if you have taken more Lacosamide Accord than prescribed. Do not attempt to drive. You may experience:

• dizziness,
• nausea or vomiting,
• seizures (epileptic fits), heart problems such as slow, fast or irregular heartbeat, coma, or low blood pressure with rapid heartbeat and sweating.

If you forget to take Lacosamide Accord

• If you forget to take a dose of Lacosamide Accord and it is less than 6 hours since your usual time, take Lacosamide Accord as soon as you remember.
• If you forget to take a dose and it is more than 6 hours past your usual time, do not take the missed tablet. Instead, take your next dose at the usual time.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking Lacosamide Accord

• Do not stop taking Lacosamide Accord without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue treatment with Lacosamide Accord, they will give you instructions on how to gradually reduce the dose.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects affecting the nervous system, such as dizziness, may be more frequent after a single "loading" dose.
If you experience any of the following symptoms, consult your doctor or pharmacist:
Very common: may affect more than 1 in 10 people

• Headache
• Dizziness or nausea
• Double vision (diplopia)

Common: may affect up to 1 in 10 people

• Brief spasms in a muscle or group of muscles (myoclonic jerks);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, tremors, tingling (paraesthesia), muscle spasms, increased tendency to fall or bruise;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of spinning (vertigo), feeling of drunkenness;
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
• Reduced touch or sensitivity, difficulty articulating words, attention disturbance;
• Ringing noises in the ears such as buzzing, ringing, or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue or weakness (asthenia);
• Itching, irritation.

Uncommon: may affect up to 1 in 100 people

• Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (cardiac conduction disorder);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not present;
• Allergic reaction following medicine intake, hives;
• Blood tests may show abnormal liver function, liver damage;
• Suicidal thoughts or thoughts of self-harm, suicide attempt: inform your doctor immediately;
• Feeling of anger or agitation;
• Abnormal thoughts or loss of contact with reality;
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
• Fainting;
• Abnormal involuntary movements (dyskinesia).

Not known: frequency cannot be estimated from the available data

• Fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high fever, and increased frequency of infections. Blood tests may show a severe decrease in the number of cells of a specific class of white blood cells (agranulocytosis);
• Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cells (eosinophilia);
• Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• Seizure

Other side effects in children
Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, abnormal behaviour, and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacosamide Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. and on the
blister after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lacosamide Accord contains
The active substance is lacosamide.
One tablet of Lacosamide Accord 50 mg contains 50 mg of lacosamide.
One tablet of Lacosamide Accord 100 mg contains 100 mg of lacosamide.
One tablet of Lacosamide Accord 150 mg contains 150 mg of lacosamide.
One tablet of Lacosamide Accord 200 mg contains 200 mg of lacosamide.
The other components are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose (L), hydroxypropylcellulose (low
substituted), anhydrous colloidal silica, crospovidone and magnesium stearate.
Coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), soy lecithin and
colourants*
* The colourants are:
50 mg tablet: iron oxide red (E172), iron oxide black (E172), indigo carmine (E132)
100 mg tablet: iron oxide yellow (E172)
150 mg tablet: iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172)
200 mg tablet: indigo carmine (E132)

Description of the appearance of Lacosamide Accord and contents of the pack
Lacosamide Accord 50 mg film-coated tablets are pink, oval-shaped, with approximate dimensions of 10.3 x 4.8 mm, marked with "L" on one side and "50" on the other.
Lacosamide Accord 100 mg film-coated tablets are dark yellow, oval-shaped, with approximate dimensions of 13.0 x 6.0 mm, marked with "L" on one side and "100" on the other.
Lacosamide Accord 150 mg film-coated tablets are salmon-coloured, oval-shaped, with approximate dimensions of 15.0 x 6.9 mm, marked with "L" on one side and "150" on the other.
Lacosamide Accord 200 mg film-coated tablets are blue, oval-shaped, with approximate dimensions of 16.4 x 7.6 mm, marked with "L" on one side and "200" on the other.
Lacosamide Accord is available in packs containing 14, 56, 60 or 168 film-coated tablets.
Packs of 14 x 1 and 56 x 1 tablets are available in divisible unit-dose blisters made of PVC-PVDC/ALU sealed with an aluminium foil; all other packs are available in standard blisters made of PVC-PVDC/ALU sealed with an aluminium foil.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
or
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,
08040 Barcelona, Spain
or
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Package leaflet: information for the patient

Lacosamide Accord 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

lacosamide
The starter pack is suitable only for adolescents and children weighing 50 kg or more, and for adults.
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Lacosamide Accord is and what it is used for
2. What you need to know before taking Lacosamide Accord
3. How to take Lacosamide Accord
4. Possible side effects
5. How to store Lacosamide Accord
6. Contents of the pack and other information

1. What Lacosamide Accord is and what it is used for

What Lacosamide Accord is
Lacosamide Accord contains the active substance lacosamide. It belongs to a group of medicines called
"antiepileptic medicines". These medicines are used to treat epilepsy.

• This medicine has been prescribed to you to reduce the number of seizures (epileptic fits) you experience.

What Lacosamide Accord is used for
Lacosamide Accord is used:

• as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially involve only one side of the brain. However, they may then spread to broader areas on both sides of the brain.

• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalised tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Lacosamide Accord

Do not take Lacosamide Accord

• if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor
• if you are allergic to peanuts or soya
• if you have a particular type of heart rhythm problem called second- or third-degree AV block.

Do not take Lacosamide Accord if any of the above apply to you. If you are unsure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Lacosamide Accord if:

• you have had thoughts of harming or killing yourself. A small number of people being treated with antiepileptic medicines such as lacosamide have had suicidal thoughts. If you experience such thoughts at any time, inform your doctor immediately.
• you have a heart condition affecting your heart rhythm and often have a particularly slow, fast, or irregular heartbeat (e.g. AV block, atrial fibrillation, or atrial flutter).
• you have a serious heart condition such as heart failure or have had a heart attack.
• you frequently experience dizziness or falls. Lacosamide Accord may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be cautious until you become accustomed to the effects of this medicine.

If any of the above apply (or if you are unsure), talk to your doctor or pharmacist before taking Lacosamide Accord. If you are already taking Lacosamide Accord, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide Accord and develop symptoms of an abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), contact your doctor immediately (see section 4).

Children

Lacosamide Accord is not recommended for children under 2 years of age. With epilepsy characterized by partial-onset seizures, and it is not recommended for children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether it is effective or safe in children within these age groups.

Other medicines and Lacosamide Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart: this is because Lacosamide Accord may also affect your heart:

• medicines used to treat heart diseases;
• medicines that can prolong the "P-R interval" on a heart scan (ECG or electrocardiogram), such as antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of irregular heartbeat or heart failure.

If any of the above apply (or if you are unsure), talk to your doctor or pharmacist before taking Lacosamide Accord.

Also inform your doctor or pharmacist if you are taking any of the following medicines – because they may increase or decrease the effect of Lacosamide Accord in your body:

• antifungal medicines called fluconazole, itraconazole, or ketoconazole;
• an antiviral medicine used to treat HIV called ritonavir;
• antibiotics used to treat bacterial infections called clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply (or if you are unsure), talk to your doctor or pharmacist before taking Lacosamide Accord.

Lacosamide Accord and alcohol

As a precautionary measure, do not take Lacosamide Accord with alcohol.

Pregnancy and breastfeeding

Women of childbearing potential should discuss the use of contraception with their doctor.

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Lacosamide Accord is not recommended during pregnancy, as the effects of lacosamide on the unborn baby are not known. It is recommended not to breastfeed while taking Lacosamide Accord, as Lacosamide Accord passes into breast milk.

Contact your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not to take Lacosamide Accord.

Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures (fits). Worsening of your condition may also be harmful to your baby.

Driving and using machines

Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Lacosamide Accord may cause dizziness or blurred vision.

Lacosamide Accord contains soya lecithin.

If you are allergic to peanuts or soya, do not take this medicine.

3. How to take Lacosamide Accord

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Other forms of this medicine may be more suitable for children: please ask your doctor or pharmacist.
How to take Lacosamide Accord

• Take Lacosamide Accord twice daily, approximately 12 hours apart.
• Try to take it at approximately the same times each day.
• Swallow the Lacosamide Accord tablet with a glass of water.
• You may take Lacosamide Accord with or without food.

You will usually start with a lower daily dose, which your doctor will gradually increase over several weeks. When the appropriate dose for you has been reached, this is called the "maintenance dose", and you should continue taking the same amount every day. Lacosamide Accord is used as a long-term treatment. You must continue taking Lacosamide Accord until your doctor tells you otherwise.
Dosage
Below are the usual recommended doses of Lacosamide Accord for different age and weight groups. Your doctor may prescribe a different dose if you have kidney or liver problems.
Adolescents and children weighing 50 kg or more, and adults
When taking Lacosamide Accord alone
The usual starting dose of Lacosamide Accord is 50 mg twice daily.
Your doctor may alternatively prescribe a starting dose of 100 mg of Lacosamide Accord twice daily.
Your doctor may increase your dose by 50 mg twice daily each week, until reaching a maintenance dose between 100 mg and 300 mg twice daily.
When taking Lacosamide Accord with other antiepileptic medicines
Starting treatment (first 4 weeks)
This package (starter pack) is intended for initiating treatment with Lacosamide Accord.
The pack contains 4 different packages for the first 4 weeks of treatment, one for each week.
Each package contains 14 tablets, corresponding to 2 tablets per day for 7 days.
Each package contains a different strength of Lacosamide Accord, allowing you to gradually increase the dose.
You will start treatment with a low dose of Lacosamide Accord, usually 50 mg twice daily, and gradually increase the dose week by week. The most commonly prescribed daily doses for the first 4 weeks of treatment are shown in the table below. Your doctor will advise you whether to use all 4 packages.
Table: Starting treatment (first 4 weeks)
Week Package to use First dose (in the Second dose (in TOTAL daily
morning) the evening) dose
Week 1 50 mg package 50 mg 100 mg
labelled "Week 1" (1 tablet of (1 tablet of
Lacosamide Accord Lacosamide Accord
50 mg) 50 mg)
Week 2 100 mg package 100 mg 200 mg
labelled "Week 2" (1 tablet of (1 tablet of
Lacosamide Accord Lacosamide Accord
100 mg) 100 mg)
Week 3 150 mg package 150 mg 300 mg
labelled "Week 3" (1 tablet of (1 tablet of
Lacosamide Accord Lacosamide Accord
150 mg) 150 mg)
Week 4 200 mg package 200 mg 400 mg
labelled "Week 4" (1 tablet of (1 tablet of
Lacosamide Accord Lacosamide Accord
200 mg) 200 mg)
Maintenance treatment (after the first 4 weeks)
After the first 4 weeks of treatment, your doctor may adjust the dose you continue taking for long-term therapy. This is called the maintenance dose and depends on your response to Lacosamide Accord. In most patients, the maintenance dose ranges between 200 mg and 400 mg per day.
Children and adolescents weighing less than 50 kg
The starter pack is not suitable for children and adolescents weighing less than 50 kg.
If you take more Lacosamide Accord than you should
Contact your doctor immediately if you have taken more Lacosamide Accord than prescribed.
Do not attempt to drive.
You may experience:

• dizziness
• nausea or vomiting;
• seizures (epileptic fits), heart rhythm problems such as slow, fast or irregular heartbeat, coma, or low blood pressure with rapid heartbeat and sweating.

If you forget to take Lacosamide Accord

• If you forget to take a dose of Lacosamide Accord and it is less than 6 hours past your usual time, take the missed dose as soon as you remember.
• If you forget to take a dose and it is more than 6 hours past your usual time, do not take the missed tablet. Take the next dose at your usual time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Lacosamide Accord

• Do not stop treatment with Lacosamide Accord without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue treatment with Lacosamide Accord, they will provide instructions on how to gradually reduce the dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or pharmacist if you experience any of the following symptoms:

Very common: may affect more than 1 in 10 people

• Headache;
• Dizziness or nausea;
• Double vision (diplopia).

Common: may affect up to 1 in 10 people

• Brief spasms in a muscle or a group of muscles (myoclonic seizures);
• Difficulty in coordinating movements or walking;
• Problems maintaining balance, tremors, tingling (paraesthesia), or muscle spasms, increased tendency to fall and bruise;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid and uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of spinning (vertigo), feeling of drunkenness;
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
• Reduced sense of touch or sensitivity, difficulty articulating words, attention disturbance;
• Ringing noises in the ear such as buzzing, ringing, or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, tiredness, or weakness (asthenia);
• Itching, irritation.

Uncommon: may affect up to 1 in 100 people

• Slowed heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (cardiac conduction disorder);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not present;
• Allergic reaction after taking the medicine, hives;
• Blood tests may show abnormal liver function, liver damage;
• Suicidal thoughts or self-harming thoughts, suicide attempt – inform your doctor immediately;
• Feeling of anger or agitation;
• Abnormal thoughts or loss of contact with reality;
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles, or lower legs;
• Fainting;
• Abnormal involuntary movements (dyskinesia).

Not known: frequency cannot be estimated from the available data

• Fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high fever, and experiencing more infections than usual. Blood tests may show a severe decrease in the number of cells of a specific type of white blood cells (agranulocytosis);
• Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cells (eosinophilia);
• Widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• Seizure.

Other side effects in children
Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, behaviour different from normal (abnormal behaviour), and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacosamide Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after Exp. and on the
blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lacosamide Accord contains
The active substance is lacosamide.
One tablet of Lacosamide Accord 50 mg contains 50 mg of lacosamide.
One tablet of Lacosamide Accord 100 mg contains 100 mg of lacosamide.
One tablet of Lacosamide Accord 150 mg contains 150 mg of lacosamide.
One tablet of Lacosamide Accord 200 mg contains 200 mg of lacosamide.
The other components are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose (L), hydroxypropylcellulose (low substituted), anhydrous colloidal silica, crospovidone and magnesium stearate.
Coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), soybean lecithin and colourants*
* The colourants are:
50 mg tablet: iron oxide red (E172), iron oxide black (E172), indigo carmine (E132)
100 mg tablet: iron oxide yellow (E172)
150 mg tablet: iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172)
200 mg tablet: indigo carmine (E132)

Description of the appearance of Lacosamide Accord and contents of the pack
Film-coated tablets of Lacosamide Accord 50 mg are pink, oval-shaped, with approximate dimensions of 10.3 x 4.8 mm, marked with the letter "L" on one side and "50" on the other.
Film-coated tablets of Lacosamide Accord 100 mg are dark yellow, oval-shaped, with approximate dimensions of 13.0 x 6.0 mm, marked with the letter "L" on one side and "100" on the other.
Film-coated tablets of Lacosamide Accord 150 mg are salmon-coloured, oval-shaped, with approximate dimensions of 15.0 x 6.9 mm, marked with the letter "L" on one side and "150" on the other.
Film-coated tablets of Lacosamide Accord 200 mg are blue, oval-shaped, with approximate dimensions of 16.4 x 7.6 mm, marked with the letter "L" on one side and "200" on the other.

The starter pack contains 56 film-coated tablets, divided into 4 packs:

• The pack labelled ‘Week 1’ contains 14 tablets of 50 mg,
• The pack labelled ‘Week 2’ contains 14 tablets of 100 mg,
• The pack labelled ‘Week 3’ contains 14 tablets of 150 mg,
• The pack labelled ‘Week 4’ contains 14 tablets of 200 mg.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
or
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,
08040 Barcelona, Spain
or
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: information for the user

Lacosamide Accord 10 mg/mL solution for infusion

lacosamide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Lacosamide Accord is and what it is used for
2. What you need to know before using Lacosamide Accord
3. How to use Lacosamide Accord
4. Possible side effects
5. How to store Lacosamide Accord
6. Contents of the pack and other information

1. What Lacosamide Accord is and what it is used for

What Lacosamide Accord is
Lacosamide Accord contains the active substance lacosamide. It belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.

• This medicine has been prescribed to you to reduce the number of seizures (epileptic fits) you experience.

What Lacosamide Accord is used for

• Lacosamide Accord is used: alone and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially involve only one side of the brain. However, they may then spread to broader areas on both sides of the brain;
• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalised tonic-clonic seizures (complex epileptic fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before using Lacosamide Accord

Do not use Lacosamide Accord

• if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor
• if you have a specific type of heart rhythm problem called second- or third-degree AV block.

Do not use Lacosamide Accord if you fall into any of the above categories. If you are unsure, speak to your doctor or
pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before using Lacosamide Accord if:

• you have had thoughts of harming yourself or committing suicide. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If you experience any such thoughts at any time, inform your doctor immediately.
• you have a heart condition affecting your heartbeat and often experience a heartbeat that is particularly slow, fast or irregular (e.g. AV block, atrial fibrillation or atrial flutter)
• you have a serious heart condition, such as heart failure or have had a heart attack.
• you frequently feel dizzy or have falls. Lacosamide Accord can cause dizziness – this may increase the risk of accidental injury or falls. This means you should be cautious until you have become accustomed to the effects of this medicine. If you fall into any of the above categories (or are unsure), speak to your doctor or pharmacist before using Lacosamide Accord. If you are taking Lacosamide Accord, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide Accord and develop symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, dizziness or fainting), consult your doctor immediately (see section 4).

Children
Lacosamide Accord is not recommended for children under 2 years of age with epilepsy
characterized by partial-onset seizures, and is not recommended for children under 4 years of
age with primary generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe in children in these age groups.
Other medicines and Lacosamide Accord
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines that
affect the heart: this is because lacosamide may also affect your heart:

• medicines used to treat heart diseases;
• medicines that can prolong the “P-R interval” on a heart scan (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
• medicines used to treat certain types of irregular heartbeat or heart failure. If you fall into any of the above categories (or are unsure), speak to your doctor or pharmacist before using Lacosamide Accord.

Also inform your doctor or pharmacist if you are taking any of the following medicines – because they
may increase or decrease the effect of Lacosamide Accord in your body:

• antifungal medicines called fluconazole, itraconazole or ketoconazole;
• an HIV medicine called ritonavir;
• medicines used to treat bacterial infections called clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression called St. John’s wort. If you fall into any of the above categories (or are unsure), speak to your doctor or pharmacist before using Lacosamide Accord.

Lacosamide Accord and alcohol
As a precautionary safety measure, do not take Lacosamide Accord with alcohol.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraceptive measures with their doctor.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult
your doctor or pharmacist before using this medicine.
It is recommended not to use Lacosamide Accord during pregnancy, as the effects of
Lacosamide Accord on the unborn baby are unknown. It is recommended not to breastfeed while taking
Lacosamide Accord, as Lacosamide Accord passes into breast milk.
Consult your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help
you decide whether or not to use Lacosamide Accord.
Do not stop treatment without first consulting your doctor, as this may lead to an
increase in seizures. Worsening of your condition may also be harmful to your baby.
Driving and using machines
Do not drive, ride a bicycle, or operate tools or machinery until you know how this
medicine affects you. This is because Lacosamide Accord may cause dizziness or blurred vision.
Lacosamide Accord contains sodium
This medicine contains 2.6 mmol (or 60 mg) of sodium (a key component of table salt)
per vial. This amount is equivalent to 3% of the maximum daily recommended sodium intake
for an adult. This should be taken into account if you are on a sodium-controlled diet.

3. How to use Lacosamide Accord

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Using Lacosamide Accord

• Lacosamide Accord may be started:
  • by taking the medicine orally, or
  • by intravenous infusion (sometimes referred to as “IV infusion”), where the medicine is administered into a vein by a doctor or nurse. It is given over a period of 15 to 60 minutes.
• The IV infusion is usually used for a short period when you cannot take the medicine by mouth.
• Your doctor will decide for how many days you will receive infusions. Data are available for two daily infusions of Lacosamide Accord for up to 5 days. For longer treatment periods, lacosamide tablets and syrup are available.

When switching from infusion to oral administration (or vice versa), the total amount you take each day and the frequency of doses remain the same.

• Use Lacosamide Accord twice daily – once in the morning and once in the evening.
• Try to use it at approximately the same time each day.

Dosage
Below are the usual recommended doses of Lacosamide Accord for different age and weight groups. Your doctor may prescribe a different dose if you have kidney or liver problems.
Adolescents and children weighing 50 kg or more, and adults
When using Lacosamide Accord alone
The starting dose of Lacosamide Accord is usually 50 mg twice daily.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 300 mg twice daily.
When using Lacosamide Accord with other antiepileptic medicines
The starting dose of Lacosamide Accord is usually 50 mg twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 200 mg twice daily.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide Accord using a single “loading dose” of 200 mg. Twelve hours later, you would then start your maintenance dose.
Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: note that Lacosamide Accord is not recommended in children below 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that Lacosamide Accord is not recommended in children below 4 years of age.

Use of Lacosamide Accord alone

• Your doctor will determine the dose of Lacosamide Accord based on your body weight.
• The usual starting dose is 1 mg (0.1 mL) per kilogram (kg) of body weight, twice daily.
• Your doctor may then increase your daily dose by 1 mg (0.1 mL) per kg of body weight twice daily each week, up to a maintenance dose.
• The dosing tables below include the maximum recommended dose.

For reference only. Your doctor will calculate the appropriate dose for you.
To be used twice daily in children from 2 years of age and weighing from 10 kg up to less than
40 kg

To be used twice daily for children and adolescents weighing 40 kg up to but less than 50 kg:

When using Lacosamide Accord with other antiepileptic medicines

• Your doctor will determine the dose of Lacosamide Accord based on your body weight.
• For children and adolescents with a body weight between 10 kg and less than 50 kg, the usual starting dose is 1 mg (0.1 mL) per kilogram (kg) of body weight, twice daily.
• Your doctor may then increase your twice-daily dose by 1 mg (0.1 mL) per kg of body weight each week, until a maintenance dose is reached.
• Dosage tables are provided below, including the maximum recommended dose. For informational purposes only. Your doctor will calculate the correct dose for you:

To be used twice daily for children from 2 years of age and with body weight between 10 kg and
less than 20 kg

To be used twice daily in children from 2 years of age with body weight between
20 kg and less than 30 kg:

In children from 4 years of age with body weight between 30 and 50 kg:

• The usual starting dose is 1 mg (0.1 mL) per kilogram (kg) of body weight, twice daily.

Your doctor may then increase your daily dose by 1 mg (0.1 mL) per kg of body weight, twice daily, each week, until a maintenance dose is reached. The maximum recommended dose is 4 mg (0.4 mL) per kg of body weight, twice daily. The dosage tables below are provided, including the recommended dose.

Use of Lacosamide Accord with other antiepileptic medicines - Children and adolescents with body weight between 30 kg and 50 kg - For reference purposes only. Your doctor will calculate the appropriate dose for you:
To be used twice daily in children and adolescents with body weight between 30 kg and less than 50 kg:

If you stop treatment with Lacosamide Accord If your doctor decides to discontinue treatment with Lacosamide Accord, the dose should be gradually reduced. This is intended to prevent the recurrence or worsening of epilepsy.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects affecting the nervous system, such as dizziness, may be more frequent after a single "loading" dose.
Contact your doctor or pharmacist if you experience any of the following symptoms:

Very common: may affect more than 1 in 10 people

• Headache
• Dizziness or nausea;
• Double vision (diplopia).

Common: may affect up to 1 in 10 people

• Brief spasms in a muscle or group of muscles (myoclonic jerks);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, tremors, tingling (paraesthesia), or muscle spasms, increased tendency to fall and bruising;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid and uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of spinning (vertigo), feeling of drunkenness;
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
• Reduced touch or sensitivity, difficulty articulating words, attention disturbance;
• Ringing noises in the ear such as buzzing, ringing, or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, tiredness or weakness (asthenia);
• Itching, irritation.

Uncommon: may affect up to 1 in 100 people

• Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of your heart (cardiac conduction disorder);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not present;
• Allergic reaction following medicine intake, hives;
• Blood tests may show abnormal liver function, liver damage;
• Self-harming thoughts or suicidal thoughts, suicide attempt – inform your doctor immediately;
• Feeling of anger or agitation;
• Abnormal thoughts or loss of contact with reality;
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles, or lower legs;
• Fainting;
• Abnormal involuntary movements (dyskinesia).

Not known: frequency cannot be estimated from the available data

• Fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high fever, and suffering from more infections than usual. Blood tests may show a severe decrease in the number of cells of a specific
  type of white blood cells (agranulocytosis);
• Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cells (eosinophilia);
• Widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• Seizure.

Other side effects when administered as intravenous infusion
Local side effects may occur.
Common: may affect up to 1 in 10 people

• Pain, discomfort, or irritation at the injection site.

Uncommon: may affect up to 1 in 100 people

• Redness at the injection site.

Other side effects in children
Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, behaviour different from normal (abnormal behaviour), and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacosamide Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Each vial of Lacosamide Accord solution for infusion must be used only once.
Any unused solution remaining must be discarded.
The solution should only be used if it is clear, with no colour alteration and free from foreign particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lacosamide Accord contains

• The active substance is lacosamide. 1 mL of Lacosamide Accord solution for infusion contains 10 mg of lacosamide. One vial contains 20 mL of Lacosamide Accord solution for infusion, equivalent to 200 mg of lacosamide.
• The other components are: sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of Lacosamide Accord and package contents

• Lacosamide Accord 10 mg/mL solution for infusion is a clear, colourless solution free from particulate matter. Lacosamide Accord solution for infusion is available in pack sizes of 1 vial and 5 vials. Each vial contains 20 mL. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6 Planta,
08039, Barcelona
Spain
Manufacturer
Accord Healthcare Polska Sp. z o.o.
Ul. Lutomierska 50,
95-200 Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola
PLA 3000, Malta
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona, Spain
Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Each vial of Lacosamide Accord infusion solution must be used only once (single use). Any unused solution must be discarded (see section 3).
Lacosamide Accord infusion solution may be administered without further dilution or may be diluted with one of the following solutions: sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%), or Ringer's lactate solution.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours between 2 and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for the product mixed with these diluents and stored in glass containers or PVC bags.